Metallic Taste Before, During and After Treatment of Head and Neck Cancer

NCT03558789 | Completed DMC

• 1 other identifier: RIPH-CHV-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Metallic taste in head and neck cancer is widely under-estimated in the literature. Its causes are multiple and poorly defined. Though it has a strong impact on the nutritional status. The main objective of the TORCAD project is to test the hypothesis that intraoral lipoperoxidation is associated to metallic taste onset before, during and after treatment of head and neck cancer (HNC). The secondary goals are to evaluate the involvement of others physiopathological factors in metallic taste: (i) additional chemical modification in the saliva; (ii) release of inhibition of the facial nerve on the glossopharyngeal nerve; presence of an intraoral electric current; food pleasantness and acceptability; quality of life.

Conditions

Metallic Taste

Outcome Measures

Primary Outcomes (1)

• Change from Baseline salivary malondialdehyde level within one year after treatment completion

  The lipoperoxidation will be measured with salivary dosage of malondialdehyde (µmol/L). As metallic taste may vary according time, the measure will be repeated.

  Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0

Secondary Outcomes (8)

• Change from Baseline métabolites levels modifications of the saliva within one year after treatment completion

  Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0

• Change from Baseline ions levels modifications of the saliva within one year after treatment completion

  Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0

• Change from Baseline enzymes levels modifications of the saliva within one year after treatment completion

  Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0

• Change from Baseline fungiform papillae density of the tonguewithin one year after treatment completion

  Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0

• release of inhibition of the facial nerve on the glossopharyngeal nerve

  Day 0 (before any treatment), before the irradiation (about 1 month ½ after Day 0), half of the irradiation (approximately 3 months after Day 0), end of irradiation (approximately 4 months after Day 0), 6-10-14 and 16 months after Day 0

Study Arms (2)

MT

patients complaining about metallic taste before, during or after treatment of head and neck cancer.

Biological: bovine lactoferrin

No-MT

patients not complaining about metallic taste before, during or after treatment of head and neck cancer.

Biological: bovine lactoferrin

Interventions

bovine lactoferrin BIOLOGICAL

mouthwash

MT; No-MT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with head and neck cancer before any treatment will be recruited. Repartition between the two groups will be performed a posteriori after onset or not of the metallic taste perception.

You may qualify if:

• Any head and neck cancer
• Before any treatment and treatment (surgery, chemotherapy, radiation therapy)
• Before the appearance of the metallic taste symptom
• Age ≥ 18 years
• Estimated life expectancy ≥ 6 months.
• Affiliation to a Social security system
• Patient who has given written consent signed before any specific procedure of the protocol

You may not qualify if:

• History of cancer (head and neck or other) that could be a confounding factor (dysgeusia, dysosmia, salivary composition disorder)
• Pregnant woman (frequent dysgeusia and dysosmia)
• Total laryngectomy (treatment-induced hyposmia)
• Early cancer recurrence (\< 6 months after the end of the last treatment) because the taste, smell, and/or composition of the saliva can be altered by the cancer itself
• Persons deprived of liberty, under guardianship or under curatorship or unable to submit to the medical follow-up of the test for geographical, social or psychic reasons

Sponsors & Collaborators

• Centre Hospitalier de Valence: lead

Study Sites (1)

CH Valence

Valence, 26953, France

Location

Related Publications (1)

• Buiret G, Brignot H, Septier C, Thomas-Danguin T, Feron G. The nutritional impact of metallic taste in head and neck cancer patients: explorations and clinical implications. Support Care Cancer. 2024 Sep 11;32(10):651. doi: 10.1007/s00520-024-08854-z.

  PMID: 39256281 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva samples

MeSH Terms

Conditions

Taste Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilles Feron, PhD

  Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: June 15, 2018
• Study Start: April 26, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 8, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)